First Quarter 2021 Net Revenues of $59 Million Increased 85% Over 2020, Driven by $27 Million in Sales of Sample Collection Devices for COVID-19 Molecular Testing
EUA Application Submitted in Q1 to FDA for COVID-19 Rapid Antigen Test for Both Prescription Home Use and Professional Use in Point of Care Settings
Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended March 31, 2021.
"OraSure had another strong quarter, as the Company delivered double-digit year-over-year revenue growth for the third quarter in a row. Our sample collection devices for COVID-19 molecular testing continue to make a significant contribution to our revenues. Moreover, we have submitted our COVID-19 rapid antigen test to the US Food and Drug Administration for Emergency Use Authorization, and look forward to bringing a prescription home test and a professional test for point of care use to market," said Stephen Tang, Ph.D., President and CEO of OraSure Technologies.
Dr. Tang continued, "As coronavirus variants continue to spread, we believe convenient, safe and accurate COVID-19 testing will continue to play a key role in identifying those who are infected and helping to safely reopen workplaces, schools, and other places where people gather. We are confident in the market potential for our COVID products, as well as the resilience of our other business segments as demonstrated by the strong first quarter performance of our commercial genomics, microbiome, and domestic HIV testing business. Given the overall strong financial performance of our business, the EUA applications pending before the FDA and our solid financial foundation, we are confident that OraSure is well positioned for continued success."
-- OraSure has collected all the data necessary to resubmit the two requested EUA applications for its oral fluid antibody test. At the FDA's request, the Company plans to submit separate EUAs for the ELISA microplate assay and the OraSure Oral Antibody Collection Device.
Financial Results for the Three Months Ended March 31, 2021
Net revenues for the first quarter of 2021 of $58.6 million increased 85% from the comparable period of 2020, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing, higher genomics product sales and increased sales by the Company's domestic HIV testing business, partially offset by declines in revenues of our international HIV products due to order timing and risk assessment products due to the impact of COVID-19 on the overall risk assessment testing market in the US.
Gross profit percentage was 65% for the three months ended March 31, 2021 compared to 51% for the three months ended March 31, 2020. Gross profit in the current quarter benefited from an improved product mix associated with higher gross profit percentage product sales.
For the three months ended March 31, 2021, operating expenses were $27.9 million, an increase of $3.7 million from the $24.2 million reported for the three months ended March 31, 2020, largely due to increased investment in the development and sale of the Company's COVID products. Operating expenses were also impacted by a benefit of $806,000 representing the change in the estimated fair value of acquisition-related contingent consideration compared to an expense of $1.1 million recorded the same period of 2020.
The Company generated operating income of $10.4 million in the first quarter of 2021 compared to an operating loss of $8.1 million in the first quarter of 2020.
During the first quarters of 2021 and 2020, the Company recorded income tax expense of $6.5 million and $712,000, respectively.
Second Quarter 2021 Guidance
The Company expects second quarter 2021 net revenues to range from $55 million to $60 million.
Financial Data (Unaudited)
Three Months Ended March 31, 2021 2020 Results of Operations Net revenues $ 58,582 $ 31,596 Cost of products and services sold 20,256 15,465 Gross profit 38,326 16,131 Operating expenses: Research and development 8,992 5,644 Sales and marketing 9,530 7,369 General and administrative 10,188 10,054 Change in fair value of acquisition-related contingent consideration (806 ) 1,110 Total operating expenses 27,904 24,177 Operating income (loss) 10,422 (8,046 ) Other income (expense) (119 ) 1,430 Income (loss) before income taxes 10,303 (6,616 ) Income tax expense 6,529 712 Net income (loss) $ 3,774 $ (7,328 ) Earnings (loss) per share: Basic $ 0.05 $ (0.12 ) Diluted $ 0.05 $ (0.12 ) Weighted average shares: Basic 71,878 61,927 Diluted 72,766 61,927
Three Months Ended March 31, Dollars Percentage of Total Net Revenues 2021 2020 % 2021 2020 Change Market Infectious disease testing $ 11,371 $ 14,664 (22 ) % 20 % 46 % Risk assessment testing 1,962 3,000 (35 ) 3 9 Molecular solutions 43,246 13,222 227 74 43 Net product and service revenues 56,579 30,886 83 97 98 Other 2,003 710 182 3 2 Net revenues $ 58,582 $ 31,596 85 % 100 % 100 %
Three Months Ended March 31, 2021 2020 % Change Infectious Disease Testing Revenues Domestic HIV $ 5,293 $ 4,216 26 % International HIV 3,486 6,949 (50 ) Net HIV revenues 8,779 11,165 (21 ) Domestic HCV 1,182 1,494 (21 ) International HCV 1,184 1,097 8 Net HCV revenues 2,366 2,591 (9 ) Other product revenues 226 908 (75 ) Net product revenues $ 11,371 $ 14,664 (22 ) %
Three Months Ended March 31, 2021 2020 % Change Molecular Solutions Revenues Genomics $ 11,064 $ 8,393 32 % Microbiome 2,088 1,577 32 COVID-19 27,389 394 N/A Laboratory services 2,497 2,415 3 Other product and service revenues 208 443 (53 ) Net product and service revenues 43,246 13,222 227 Other 790 582 36 Net revenues $ 44,036 $ 13,804 219 %
Condensed Consolidated Balance Sheets (Unaudited) March 31, 2021 December 31, 2020 Assets Cash and cash equivalents $ 177,676 $ 160,802 Short-term investments 29,080 48,599 Accounts receivable, net 36,391 38,835 Inventories 40,348 31,863 Other current assets 8,913 8,794 Property, plant and equipment, net 64,943 51,860 Intangible assets, net 16,945 17,904 Goodwill 40,493 40,351 Long-term investments 33,706 47,718 Other non-current assets 7,999 7,746 Total assets $ 456,494 $ 454,472 Liabilities and Stockholders' Equity Accounts payable $ 20,731 $ 17,407 Deferred revenue 4,580 4,811 Contingent consideration obligation 365 402 Other current liabilities 18,967 23,869 Non-current contingent consideration obligation 874 2,049 Other non-current liabilities 7,434 7,363 Stockholders' equity 403,543 398,571 Total liabilities and stockholders' equity $ 456,494 $ 454,472
Additional Financial Data (Unaudited) Three Months Ended March 31, 2021 2020 Capital expenditures $ 11,061 $ 2,595 Depreciation and amortization $ 2,489 $ 2,165 Stock-based compensation $ 1,464 $ 1,376 Cash provided by (used in) operating activities $ (4,393 ) $ 2,499
The Company will host a conference call and audio webcast for analysts and investors to discuss the Company's first quarter 2021 quarter results and certain business developments, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Dr. Stephen S. Tang, President and Chief Executive Officer, and Roberto Cuca, Chief Financial Officer. The call will include prepared remarks by management and a question and answer session.
In order to listen to the conference call, please dial 844-831-3030 (Domestic) or 315-625-6887 (International) and reference Conference ID # 1349536 or go to OraSure Technologies' web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies' web site shortly after the call has ended and will be available for 14 days. A replay of the call can also be accessed until midnight, May 19, 2021, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID # 1349536.
It is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on OraSure's Investor Relations page.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure's portfolio of products is sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.
This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management's attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration ("FDA") or other regulators; the impact of the novel coronavirus ("COVID-19") pandemic on our business and our ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company's products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention ("CDC") or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company's stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
Investor Contact: Media Contact Sam Martin Jeanne Mell Argot Partners OraSure Technologies 212-600-1902 484-353-1575 email@example.com firstname.lastname@example.org